Thus, the higher incidences observed for specific AE groups through week 160 (table 4) relative to observations through week 161 were not unexpected given follow-up periods almost 4 instances (50 mg) and more than 6 instances (100 mg) the space of placebo-controlled follow-up. crossed over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status and Group 3 managed dosing. Data through week 160 are reported. Results 459 of the 461 randomised individuals were treated; 236/459 (51%) continuing treatment through week 160. From week 24 to week 100, ACR20 (20% Picropodophyllin improvement in American College of Rheumatology criteria) response and 0.25 unit HAQ (Health Assessment Questionnaire) improvement were sustained in 70C73% and 75C81% of responding patients, respectively. Overall at week 160, 63%, 67% and 57% of individuals accomplished ACR20 response and 59%, 65% and 64% experienced HAQ improvement 0.25 unit in Organizations 1, 2 and 3, respectively. Adjusted for follow-up period, adverse event incidences (95% CI) per 100 patient-years among patients treated with golimumab 50 mg and 100 mg were 4.70 (2.63 to 7.75) and 8.07 (6.02 to 10.58) for serious infection, 0.95 (0.20 to 2.77) and 2.04 (1.09 to 3.49) for malignancy and 0.00 (0.00 to 0.94) and 0.62 (0.17 to 1 1.59) for death, respectively. Conclusion In patients with active RA who Picropodophyllin discontinued previous TNF-antagonist treatment, golimumab 50 and 100 mg injections every 4 weeks yielded sustained improvements in indicators/symptoms and physical function in 57C67% of patients who continued treatment. Picropodophyllin Golimumab security was consistent with other anti-TNF brokers, although definitive conclusions regarding long-term safety require further monitoring. Tumour necrosis factor alpha (TNF) inhibitors have been used to treat rheumatoid arthritis (RA) for >10 years. Patients with insufficient response to TNF inhibitors are routinely switched to other biological brokers, including other TNF inhibitors. Thus, increasingly more patients with RA have previous experience with 1 TNF inhibitor. Among the newer anti-TNF brokers, golimumab is usually a human monoclonal anti-TNF agent administered subcutaneously every 4 weeks. GO-AFTER (GOlimumab After Former antitumour necrosis factor Therapy Evaluated in Rheumatoid arthritis) was the first prospective, randomised, phase 3, double-blind, placebo-controlled trial to assess a TNF inhibitor in patients with active RA who previously received TNF inhibitor(s). These patients experienced also received several disease-modifying antirheumatic drugs (DMARDs) prior to TNF inhibitor(s), thereby representing a difficult-to-treat populace. Treatment with golimumab 50 mg and 100 mg every 4 weeks versus placebo yielded significantly higher ACR20 (20% improvement in American College of Rheumatology criteria) response rates at week 14 (35% and 38% vs 18%, respectively; both p<0.001) and no unexpected safety issues through week 24.1 Efficacy and safety findings through week 160 of the GO-AFTER long-term extension (LTE) are reported herein. Patients and methods GO-AFTER ("type":"clinical-trial","attrs":"text":"NCT00299546","term_id":"NCT00299546"NCT00299546) was conducted according to the Declaration of Helsinki. All patients provided written informed consent, and the protocol was approved by each institution’s human subjects ethical evaluate board. Patients Patient enrolment began 21 February 2006; data were collected at visits conducted through LTE week 160. Eligible patients with RA2 experienced active disease (4 swollen, 4 tender joints); had previously received etanercept, adalimumab or infliximab for 8 (adalimumab, etanercept) or 12 (infliximab) weeks; and could have discontinued these brokers for any reason (documented as lack of efficacy, intolerance, other). Additional inclusion/exclusion criteria were previously reported.1 Study design Patients were randomised (1:1:1) to receive subcutaneous injections of placebo, golimumab 50 mg or golimumab 100 mg every 4 weeks. Stable doses of synthetic DMARDs were allowed. Patients and investigators were blinded to treatment assignment; golimumab and placebo were supplied in identical single-use vials. Gja5 Patients in the placebo and golimumab 50 mg groups with <20% Picropodophyllin improvement in both tender and swollen joint counts at week 16 early escaped (EE) to receive golimumab 50 mg or 100 mg, respectively, at week 16 and week 20. Dosing was not changed in the 100 mg group. GO-AFTER included a LTE. From week 24 forward, patients in the placebo group crossed over to golimumab 50 mg every 4 weeks and patients in the golimumab 50 mg group continued with golimumab 50 or 100 mg every 4 weeks per EE status. The study blind was managed during the LTE until the week 24 database lock, after which patients receiving golimumab 50 mg could escalate to 100 mg at the investigator's discretion. Golimumab doses could not be reduced through week 160. Procedures Clinical response through week 160 was assessed using ACR20/50/70,3 28-joint count Disease Picropodophyllin Activity Score (DAS28) response (good/moderate) and DAS28 remission (score<2.6) criteria.4C6 DAS28 scores were determined using erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) with established slice points for disease activity says.7 Clinical.